Product Pipeline

Our Goal is to make a Significant Impact on Metabolic Diseases

We are maximizing the potential of innovative molecules to make an impact on metabolic diseases, particularly in type 2 diabetes and NASH. Our commitment is to develop innovative, safe and effective treatment options for patients.

Why Our Focus is on Metabolic Diseases

Type 2 diabetes is one of the world's major health concerns and its incidence is growing rapidly. It is the most common form of diabetes, affecting about 90% of diabetic patients.

The Challenge with the Current Standard of Care

The current standard of care for the majority of patients is limited by the fact that none of the available therapeutic options is satisfactorily effective in controlling the disease and marketed therapeutics are associated with safety and tolerability side effects as well as weight gain and hypoglycemia.

Candidate

Indication

MoA

Preclinical

Phase 1

Phase 2

Phase 3

Partner/Rights

Next Steps

Imeglimin Japan / Asia

Type 2 Diabetes

Mitochondrial bioenergetics

Preclinical complete

Phase 1 complete

Phase 2 complete

Phase 3 in progress

Expected development status: Phase 3Phase 3

Ph 3 TIMES completion

Target JNDA submission 2020

Imeglimin US / EU and other countries WW

Type 2 Diabetes

Mitochondrial bioenergetics

Preclinical complete

Phase 1 complete

Phase 2 in progress

Expected development status: Phase 3Phase 3

Phase 3 not started

Manufacturing drug for Ph 3

Differentiation studies in CKD patients w/ T2D

PXL770

NASH/metabolic diseases

Direct AMPK activator

Preclinical complete

Phase 1 in progress

Expected development status: Phase 2Phase 2

Phase 2 not started

Phase 3 not started

Complete MAD study mid-2018

Initiate Ph 2a in NASH 2H 2018

PXL007 (EYP001)

Hepatitis B/NASH

FXR Agonist

Preclinical complete

Phase 1 in progress

Expected development status: Phase 2Phase 2

Phase 2 not started

Phase 3 not started

Complete Ph 1 program by Enyo Pharma

PXL065 (formerly DRX-065)

NASH

MPC Inhibitor

Preclinical complete

Phase 1 in progress

Expected development status: Phase 2Phase 2

Phase 2 not started

Phase 3 not started

Complete Ph 1, tox, CMC

Initiate Ph 2

Poxel / DeuteRx metabolic programs

Metabolic diseases (AMN/ALD, etc..)

Direct AMPK activator/ MPC Inhibitor

Preclinical in progress

Expected development status: Phase 1Phase 1

Phase 1 not started

Phase 2 not started

Phase 3 not started

Complete pre-clinical studies

Open arrow designates expected development status in 2019.

Imeglimin

Imeglimin is the first orally-available anti-diabetes drug candidate that simultaneously targets all three key organs of diabetes, which includes the pancreas, liver, and muscles.

Japan/Asia

The steady growing, ~$4B* Japanese diabetes market offers a unique value creation opportunity. In Japan, China and 11 other Asian countries, Sumitomo Dainippon Pharma is our strategic partner for Imeglimin. For Japan, Poxel and Sumitomo Dainippon Pharma are jointly conducting the Phase 3 TIMES program for Imeglimin, which is being funded by Sumitomo Dainippon Pharma, and they will commercialize the product for this market. In China, South Korea, Taiwan and nine other Southeast Asian countries including Indonesia, Vietnam, Thailand, Malaysia, the Philippines, Singapore, Myanmar, Cambodia, and Laos, Sumitomo Dainippon Pharma will be solely responsible for the development and commercialization of Imeglimin.

U.S. and E.U.

The U.S. and European market provides a ~$32B* market opportunity. We have a strategic development and license agreement with Roivant Sciences for Imeglimin in the U.S., Europe, and other countries worldwide not covered by Poxel’s agreement with Sumitomo Dainippon Pharma. Phase 3 program-related work for imeglimin will commence in 2018 with the goal of initiating a Phase 3 program in the U.S. and Europe in 2019.

PXL770

PXL770 directly activates adenosine monophosphate-activated protein kinase (AMPK), an enzyme that controls whole-body energy metabolism. Through its unique mechanism of action that directly activates AMPK, PXL770 acts on a very important biological target. This target has the potential to treat chronic metabolic diseases, including diseases that affect the liver, such as non-alcoholic steatohepatitis or NASH.

PXL065 (DRX-065)

PXL065 (DRX-065) (deuterium-stabilized R-pioglitazone), is a mitochondrial pyruvate carrier (MPC) inhibitor that is currently in Phase 1 development. PXL065 (DRX-065) is the R-stereoisomer (single isomer) of pioglitazone. Pioglitazone, a drug approved for the treatment of type 2 diabetes, has demonstrated efficacy in NASH and is currently the only drug recommended in practice guidelines for biopsy-proven NASH patients1. However, pioglitazone’s use has been limited in NASH due to its side effect profile, which includes weight gain, bone fractures and fluid retention. PXL065 (DRX-065), a novel patent-protected drug candidate, offers a new approach for the treatment of NASH with the potential for similar efficacy and a reduction of side effects associated with the parent drug, pioglitazone.

1. J Hepatol. 2016, 64(6),1388-402; Hepatology 2018, 67, 328-357

PXL007 (EYP001)

Through a licensing agreement with Enyo Pharmaceuticals, EYP001, an FXR agonist, is in a Phase 1 study for the treatment of Hepatitis B.